Cardiac Involvement in Patients with Duchenne/Becker Muscular Dystrophy

March 17, 2025 updated by: University Children's Hospital, Zurich
This study evaluates the function of the heart in young patients with muscular dystrophy type Duchenne or Becker. Participants have their hearts examined at regular intervals by ultrasound (echocardiography) and cardiac magnetic resonance imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Muscular dystrophy leads to progressive loss of function in all muscles during childhood and adolescence, including the heart. The usual method to evaluate the heart is echocardiography, emphasizing few parameters. Cardiac magnetic resonance imaging is not as widely available as echocardiography, but early changes can be detected before they become visible on echocardiography. In this study, the investigators compare the methods of measuring heart function in order to find the best measurements for follow up and to see how fast the degenerative changes occur in the hearts of patients with muscular dystrophy.

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zürich, ZH, Switzerland, 8032
        • Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
  • Control group for CMR: children without heart disease

Description

Inclusion Criteria:

  • Boys aged 8 to 18 years with DMD/BMD confirmed genetically or by muscle biopsy
  • Informed consent

Exclusion Criteria:

  • Other clinically significant concomitant disease states (e.g., renal failure)
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant or his/her parents or legal caregivers,
  • Inability to lie still for the duration of the imaging procedures (approximately 45 minutes each for echocardiography and CMR)
  • MR-incompatible implanted or accidentally incorporated metal device or claustrophobia that prohibits use of magnetic resonance imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with muscular dystrophy
Boys aged 8 to 18 years with muscular dystrophy of the Duchenne / Becker type
Children without heart disease
Children without heart disease, aged 8-18 years, as CMR comparison group
Other: Observation
Observation by serial echocardiography with extended techniques and cardiac magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left ventricular ejection fraction
Time Frame: 3 years per patient
3 years per patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantification of fibrosis by LGE/T1 mapping
Time Frame: 3 years per patient
3 years per patient
NT-proBNP
Time Frame: 3 years per patient
3 years per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Barbara EU Burkhardt, MD, Children's Hospital Zürich, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

March 22, 2022

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

June 10, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimated)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMD-Herz

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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